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Recruiting Phase 1/2

To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

NCT06378242 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2024-06-14
Last updated
2024-07-11

Condition(s) studied

High-risk Non-muscle Invasive Bladder Cancer

Investigational drug(s) / intervention(s)

Disitamab Vedotin for injection →

Disitamab Vedotin for injection: Intravesical instiliations into the bladder

Study summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Voluntary consent to participate in the study and signed the informed consent form. 2. Male or female, age 18-75 years (including both). 3. Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group. Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the following: a.Carcinoma in situ (CIS) b. T1 stage c. diameter\>3cm d.Multiple tumors, or recurrent tumors. 4. Absence of resectable disease(Ta and/or T1 disease) after transurethral resection (TURBT) procedures (residual CIS acceptable; 5. The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer. 6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 8. Adequate heart, bone marrow, liver, kidney and coagulation function Exclusion Criteria: * 1\. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis. 2\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis). 3\. Any other antitumor therapy received within 4 weeks before study administration, . 4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose. 5, Known allergic to DV and its components or to any excipients.

Primary outcome measure(s)

  • Incidence of dose-limiting toxicity(DLT) (Phase I) — Approximately 21 days
  • Incidence of Adverse event (Phase I) — Approximately 1 years
    According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade
  • Recommended Phase II Dose(RP2D) — Approximately 21 days
    Assessed based on the Incidence of DLT
  • Maximum Tolerated Dosage(MTD) — Approximately 21 days
    Assessed based on the Incidence of DLT

Trial sites (6)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital,SunYat-sen University Guangzhou Guangdong Recruiting
Tongji Hospital Wuhan Hubei Not Yet Recruiting
Hunan Cancer hospital Changsha Hunan Recruiting
The first affiliated hospital with nanjing medical universtity Nanjing Jiangsu Not Yet Recruiting
West China Hospital Chengdu Sichuan Not Yet Recruiting
Tianjin Medical University Second Hospital Tianjin Tianjin Municipality Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06378242 on ClinicalTrials.gov ↗ ← All trials in China